Health Highlights: April 18, 2014
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Scientists Create First Embryo Clones Using Cells From Adults
For the first time, scientists say they have used material from cells from two adults to create early stage cloned embryos. They then used those embryos to create tissue that was an exact genetic match of the donors.
The aim of the research is to be able to grow tissue in the laboratory from patients' own cells that could be used to treat a wide range of diseases, the Wall Street Journal reported.
The study, published April 17 in Cell Stem Cell, is the first to create cloned embryos with adult cells -- last year, similar results were achieved using infant and fetal cells.
"The proportion of diseases you can treat with [lab-made tissue] increases with age. So if you can't do this with adult cells, it is of limited value," Robert Lanza, co-author of the study and chief scientific officer at Advanced Cell Technology Inc. of Marlborough, Mass, told the WSJ.
In the latest research, funded by the government of Korea and performed at a lab in California, the adult cells used came from one 35-year-old man and one 75-year-old man.
Shoukhrat Mitalipov, a development biologist at Oregon Health and Science University, in Portland, was the leader of the 2013 study that produced cloned embryos from infant or fetal cells. He told the WSJ that he was "happy to hear that our experiment was verified and shown to be genuine."
According to the newspaper, the embryos resulting from Lanza's research may have limitations that prevent them from ever producing a human clone, even if they were implanted in a womb. And experts stress that the creation of a human clone is certainly not on the horizon -- researchers have unsuccessfully tried to create a cloned monkey for years.
Still, this line of research has some worried. "If we're closer to some rogue scientist or fertility doctor using published techniques to create cloned humans, it certainly ups the stakes and means we should be moving to put a federal law in place," Marcy Darnovsky, executive director of the Center for Genetics and Society, a nonprofit public interest group in Berkeley, Calif, told the WSJ.
Lowe's Agrees to Stricter Oversight of Lead Paint Renovations: EPA
The nationwide home-improvement retailer Lowe's Home Centers has agreed to adopt a "comprehensive, corporate-wide compliance program" to minimize lead paint dust created during home renovations, the U.S. Environmental Protection Agency (EPA) announced Thursday.
The program will govern contractors that Lowe's hires to do home-repair work through its more than 1,700 stores, the agency said in a news release.
Lead dust problems can surface when lead paint breaks down or is dislodged during home renovation work. Exposure to lead can cause a variety of health problems, ranging from behavioral disorders and learning disabilities to seizures and death. Young children are most vulnerable because their nervous systems are still developing, according to the EPA.
Lead-based paint was banned in the United States in 1978, but it can still be found in many houses and apartments.
The settlement includes a $500,000 civil penalty, the largest of its kind. It was prompted after EPA inspectors discovered violations of the federal Lead Renovation, Repair, and Painting Rule, the news release said.
The violations were linked to Lowe's stores in Arkansas, Connecticut, Idaho, Illinois, Ohio, New Hampshire, New York, Tennessee and Vermont, the EPA said.
Guinea Ebola Outbreak Caused by New Virus Strain: Researchers
The Ebola outbreak in West Africa is being caused by a new strain of the virus that did not spread there from other regions of Africa, researchers say.
Most of the more than 120 deaths in the outbreak have been in Guinea, the Associated Press reported.
The international team of scientists analyzed blood samples from 20 Ebola patients in the current outbreak and concluded that they had a unique strain. The findings were published online Wednesday in the New England Journal of Medicine.
"The source of the virus is still not known," but it did not come from neighboring countries, said Dr. Stephan Gunther of the Bernhard Nocht Institute for Tropical Medicine in Hamburg, Germany, the AP reported.
Previously, health officials said the Ebola outbreak in Guinea and surrounding countries was caused by a Zaire strain. Zaire is the former name of the Democratic Republic of Congo.
But Gunther said the Guinea Ebola is not from the Democratic Republic of Congo or from Gabon, where Ebola has also occurred, the AP reported.
The researchers believe that the Guinea outbreak began last December or earlier and may have gone unrecognized for some time. Efforts to pinpoint "the presumed animal source," are continuing, they wrote.
There is no cure or vaccine for Ebola.
Oil-Swishing Craze: Snake Oil or All-Purpose Remedy?
Some people swear by the practice, but little research exists to back up health claims
FRIDAY, April 18, 2014 (HealthDay News) -- Allison Bennett of Palm City, Fla., plans to swish daily. Sloshing coconut oil around her mouth for a quarter of an hour every day will make her teeth whiter, she believes.
Like Bennett, plenty of consumers are discovering an ancient practice called oil pulling, or oil swishing. Some people report the practice sweetens their breath; others say it treats gum disease, prevents tooth decay and even improves arthritis and asthma.
Oil pulling, which goes back 2,500 years, is based on Indian traditional medicine, or Ayurveda, said Marc Halpern, a chiropractor and president of the California College of Ayurveda, in Nevada City, Calif.
The practice is based on a core concept of Ayurveda: that oil is nourishing to body tissue, said Halpern. "In Ayurveda we oil all the tissues of the body, from head to toe, every day. Studies have shown there can be an antimicrobial and anti-inflammatory action."
Halpern swishes oil. "I try to do everything within the realm of Ayurveda to see if it's of value," he said.
But even Halpern admits that oil pulling may not produce the broad range of benefits some boast. "People have reported all kinds of wonderful results from doing it, but you can't attribute every result to the practice," he said.
Hard evidence of the benefits and risks is hard to come by.
Bennett decided to try swishing after applying coconut oil to her 2-year-old daughter's skin to treat eczema. In reading about how the oil worked, she learned about pulling. So she recently ordered another bottle of coconut oil and tried it.
"It wasn't bad," said Bennett, who swished for 10 to 15 minutes. "My mouth seemed quite clean after and my teeth seemed whiter even after just one time. I plan to make this a part of my daily routine each morning."
Do experts in Ayurveda think pulling really works as a teeth whitener? "It hasn't been studied," said Halpern.
As for any downside, Halpern said some people feel a little nauseous when they swish. For that he recommends using oil for just five minutes, not the 20 minutes some recommend, and using less oil if need be.
"Between a teaspoon and a tablespoon is fine. There is no exact amount of oil that must be put in your mouth," he said.
While Halpern said he believes swishing oil is safe, he recommends that people work with a trained and experienced Ayurveda practitioner to get a personalized "prescription" for the type of oil that best fits their needs and physical make-up.
Lydia Hall, a spokeswoman for the American Dental Association, said the association can't comment on oil pulling because additional research is needed. And the National Institute of Dental and Craniofacial Research isn't doing any research on oil pulling, said its spokesman, Bob Kuska.
Some experts say almost anything you do for your mouth is better than neglecting it.
"Anyone who wants to pay attention to their oral hygiene, it's a good thing," said Dr. Joseph Banker, a cosmetic dentist in Westfield, N.J. "But are there other things that they could be doing? Probably."
Many "old remedies" were developed when there was no toothpaste, mouthwash, floss or toothbrushes, Banker said. Nowadays, inexpensive and widely available tools make it a lot easier to take care of your teeth and gums, he added.
As for whether swishing can whiten teeth, Banker is skeptical. "I don't think the oil has an intrinsic effect other than the removal of plaque. It's hard to find a study that states that. Anything that swishes around for 20 minutes may have some effect, even water."
Yet if done daily, oil pulling may remove some tooth stain, Banker said. Also, if the process improves gum health, they will be pinker, which can often make the teeth look whiter, he said.
Banker recommends that people who want brighter teeth simply use whitening strips. "They're easy to place, and you can stop using them if your teeth get sensitive."
But could swishing do harm? "No. It's the ones who ignore their mouths that have problems," said Banker.
Learn more about oral health from the U.S. Centers for Disease Control and Prevention ( http://www.cdc.gov/oralhealth/ ).
SOURCES: Marc Halpern, D.C., C.A.S., president, California College of Ayurveda, Nevada City, Calif.; Joseph Banker, D.M.D, cosmetic dentist, Westfield, N.J.; Allison A. Bennett, Palm City, Fla.; Lydia Hall, spokeswoman, American Dental Association, Chicago; Bob Kuska, spokesman, National Institute of Dental and Craniofacial Research, Bethesda, Md.
Suddenly Health Insurance Is Not for Sale
People hoping to buy private coverage for 2014 could be out of luck, but some windows may exist
FRIDAY, April 18, 2014 (HealthDay News) -- Darlene Tucker, an independent insurance broker in Scotts Hill, Tenn., says health insurers in her area aren't selling policies year-round anymore.
People who didn't try to sign up for health insurance by March 31 may now have to wait until the end of the year to buy a health plan -- even outside the new Obamacare marketplaces, she noted.
"I'm very concerned that there are going to be people that develop health problems that begin walking into our doors and say, 'I need to get health insurance ... I need to be able to see the doctor,'" Tucker said. "And we're going to have to tell them that nothing's available."
It's a little-understood consequence of the Affordable Care Act, known as Obamacare.
Millions of uninsured Americans who missed the sign-up period -- perhaps hoping to shop for coverage at their own convenience -- may soon find they can no longer buy comprehensive coverage whenever they want.
"If somebody needs insurance in the middle of the year, in some places, they won't have access to it," said Kathryn Gaglione, a spokeswoman for the National Association of Health Underwriters in Washington, D.C., which represents health insurance agents and brokers across the nation.
For health insurers, it's an economic decision. To stay viable, they need to attract a certain mix of people, including young, healthy folks who don't require expensive care, or any care at all. If health plans leave the door open year-round, they're likely to attract people who are very sick, newly diagnosed and in need of immediate care. And under the health reform law, health insurers cannot turn these sickest patients away.
Insurers react to new rules
Many uninsured Americans will pay a federal tax penalty during next year's tax season, and people who procrastinated may have to wait until the next open enrollment period, starting Nov. 15, to enroll in coverage that takes effect in 2015.
So why cut off enrollment now? Experts say insurers are simply reacting to the health law's incentives.
The Affordable Care Act prohibits most health insurers from denying coverage to people with pre-existing medical conditions. The exception is for so-called grandfathered plans that were in place before the law took effect.
To discourage folks from waiting until they're sick to buy coverage, health plans offered on the federal and state marketplaces, or exchanges, are available only during open enrollment and under special circumstances -- say, a move, divorce or birth of a child.
Healthy young adults for the most part are not the ones scrambling to sign up. They've already weighed the cost versus the benefit and decided to hold onto their premium dollars, brokers said.
Limiting open enrollment minimizes the risk of attracting mostly sick people in dire need, which would make health insurance unaffordable for everyone.
"What they should have done is said, 'Look, you can always enroll in a health insurance plan any time of the year. However, it doesn't cover any pre-existing conditions if you enroll outside of the open enrollment period,' " said Robert Slayton, an independent broker in Naperville, Ill.
Exchange plans don't have a choice, but off-exchange health insurers can decide when to offer coverage, said Carrie McLean, director of customer care for the online insurance broker eHealthInsurance. They can limit enrollment to a designated period mirroring the Obamacare sign-up and special enrollment periods. Or, they can sell insurance year-round, she explained.
Few are choosing to leave the door wide open, insurance brokers said.
"I think the biggest misconception was that [consumers] would just get the tax penalty" if they missed the March 31 open enrollment deadline, McLean noted. "People really did not understand that you couldn't get insurance at all," she said.
Of the more than 180 insurance carriers its works with across the United States, eHealthInsurance has identified just 14 states where at least one insurer has agreed to accept new applications off-exchange, mostly through April 15 or April 30.
'People did not understand that you couldn't get insurance at all'
There are a few exceptions.
Meritus, a Tempe, Ariz.-based nonprofit health insurer, said it intends to sell coverage outside of open enrollment. The consumer-owned and -operated health insurer is currently confirming its plan with the Arizona Department of Insurance.
"Due to the large number of people who did not enroll during open enrollment, we feel that providing an opportunity for people to still secure coverage is important to the community," Meritus CEO Kathleen Oestreich told HealthDay.
"We understand there may be additional risk, but we are prepared to manage that risk," she added.
Nevada Health Co-op, a nonprofit health insurer in Las Vegas, is also extending enrollment beyond April.
"They ought to put a kiosk in the emergency rooms, because who's going to be signing up? It's going to be people who desperately need insurance right now," said Larry Harrison, an independent broker in Las Vegas.
The rollout of Obamacare was marred by extensive computer glitches that hampered many Americans trying to sign up for coverage. The recent resignation of U.S. Health and Human Services Secretary Kathleen Sebelius may have been partly due to the fallout from that botched launch.
Consumers in most states had until April 15 to complete the enrollment process. People who submitted paper applications to the federal marketplace by April 7 have until the end of the month to select a plan.
Visit HealthCare.gov to find out how to complete an insurance application (https://www.healthcare.gov/what-if-i-tried-to-enroll-by-march-31-but-didnt-finish-in-time ).
SOURCES: Darlene Tucker, independent insurance broker, Scotts Hill, Tenn.; Kathryn Gaglione, spokeswoman, National Association of Health Underwriters, Washington, D.C.; Robert Slayton, independent broker, Naperville, Ill.; Carrie McLean, director, customer care, eHealthInsurance, Mountain View, Calif.; Kathleen Oestreich, CEO, Meritus, Tempe, Ariz.; HealthCare.gov
Most Medical Devices Approved for Kids Only Tested on Adults: Study
Children need inclusion in clinical trials to ensure safety, effectiveness, researchers say
THURSDAY, April 17 (HealthDay News) -- Most medical devices approved for use in children are not tested on pediatric patients before they are marketed, a new Harvard study finds.
Since Congress passed the Pediatric Medical Device Safety and Improvement Act in 2007, which was designed to stimulate the development of pediatric devices, children have made up only 10 percent of participants in clinical trials, the researchers report.
"Many devices that are approved by the U.S. Food and Drug Administration for use in children have had only very limited study in actual pediatric patients," said lead researcher Dr. Florence Bourgeois, a pediatric emergency medicine specialist at Boston Children's Hospital.
"Patients and physicians should be aware of the limitations in the safety and efficacy data of pediatric devices when making treatment decisions," she said.
Even after a number of regulatory initiatives to increase the number of devices studied and approved for use in children, research on these devices before or after approval remains limited.
"Specifically, we found that in a sample of high-risk devices recently approved for use in children, 84 percent were approved by the FDA without pre-market study in any patients younger than 18 years old," Bourgeois said.
In the clinical trials supporting FDA approval of the devices in children, less than 5 percent of all participants were younger than 18, she added.
Among the 25 devices the researchers examined, most were heart devices, such as implantable cardiac defibrillators or stents. Others included devices for children with severe asthma or undergoing spinal surgery, Bourgeois said.
"Not only were many of these devices tested in limited pediatric populations, but many were also approved on the basis of clinical trials that did not employ a very rigorous trial design," she said.
These findings imply that most devices developed by manufacturers for adults are later approved for children despite the limited evidence of their safety and effectiveness in this group, Bourgeois said.
"Future efforts to increase the availability of medical devices to pediatric patients should insure that devices are adequately studied in pediatric patients both in pre-market and post-marketing studies," she said.
The report was published online April 14 and in the May print issue of Pediatrics.
One regulatory agency representative pointed out a different problem: Few new devices are being developed that are specifically intended for children.
FDA Spokeswoman Susan Laine said, "It's important to note that the study referenced included very few devices indicated for pediatric populations younger than 18 years of age. This underscores the challenges of not only evaluating products for these younger populations, but also getting companies to invest in product development for these age groups."
FDA evaluates all devices for safety and effectiveness based on the indications and data provided by the sponsor, Laine said.
"Because of the small populations involved in pediatrics, many devices may be approved by the Humanitarian Device Exemption pathway, which provides an alternate marketing path if certain criteria are met for rare conditions," she said. "The FDA considers flexible and adaptive clinical trial designs when reviewing devices in any small population. Additionally, the FDA takes into consideration the availability of alternative treatment options."
For the study, the researchers looked at the pre- and post-market testing of devices the FDA considers Class III, or high risk.
Bourgeois' team found that of 22 devices approved for use in kids, 88 percent were only being tested on adults 18 and older. This was possible because the FDA Center for Devices and Radiologic Health considers patients between 18 to 21 to be children, the researchers noted.
Most of the devices approved were not tested in randomized trials -- which are considered the gold standard for clinical trials.
Although the FDA required post-marketing studies of 19 devices once they were in clinical practice, only three required testing on children, the researchers noted.
One expert said the new findings did not come as a surprise.
"This is something those of us in pediatrics have known for a long time," said Dr. Michael Duchowny, a pediatric neurologist and director of academic affairs at Miami Children's Hospital Research Institute.
"It's not just with devices, but with medications as well. About 80 percent of the medications we prescribe have never undergone clinical trials in children," he said. "There are inadequate trials for devices and medications in children."
The effect is a lack of data on devices and drugs used for children, Duchowny said.
Often drugs and devices are used "off label" in children, he said. Duchowny believes the FDA should give companies incentives to test their drugs and devices in children.
For more about medical devices, visit the U.S. Food and Drug Administration (http://www.fda.gov/MedicalDevices/ ).
SOURCES: Florence Bourgeois, M.D., M.P.H., pediatric emergency medicine, Boston Children's Hospital; Michael Duchowny, M.D., pediatric neurologist, and director, academic affairs, Miami Children's Hospital Research Institute; Susan Laine, spokeswoman, U.S. Food and Drug Administration; May 2014 Pediatrics
FDA Approves Under-the-Tongue Hay Fever Pill
Ragwitek helps the body immunize itself against the offending plant
THURSDAY, April 17, 2014 (HealthDay News) -- A novel treatment for the hay fever that plagues millions of Americans every fall was approved Thursday by the U.S. Food and Drug Administration.
The first hay fever pill to be placed under the tongue once a day, Ragwitek can be taken by adults aged 18 to 65, the FDA said in a news release.
Treatment is typically started three months before the start of ragweed pollen season, and patients keep taking it throughout the season. The first dose is taken in a health care professional's office, so the patient can be monitored for any adverse reactions to the pill. After that, Ragwitek can be taken at home, the FDA said.
"The approval of Ragwitek offers millions of adults living with ragweed pollen allergies [hay fever] in the United States an alternative to allergy shots to help manage their disease," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the news release.
A product of Merck & Co., Ragwitek is made of ragweed pollen and helps the body become immune to it. In the United States, the ragweed season usually starts in September and runs through the fall.
People suffering from ragweed allergy suffer stuffy noses with sneezing, itching and congestion, as well as itchy and watery eyes. These annoying symptoms can affect quality of sleep and hamper daily activities. Plus, these problems often precede the development of asthma.
Current treatments include a variety of nasal sprays, as well as shots specifically tailored to tame all of a patient's allergies.
Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, has expressed doubts in the past about the power of the new pill. He said people who are allergic to ragweed often are allergic to other plants as well.
"I am skeptical that the pill will work on these other plant allergies," he told HealthDay.
Another expert, however, said he sees this as a first step in making this kind of allergy treatment a possibility.
"The whole idea of [under-the-tongue] immunotherapy has been in the background for some time," said William Blouin, an allergy and immunology nurse practitioner at Miami Children's Hospital. "Until this point, immunotherapy has to be done as a series of injections."
A pill would make life simpler, he said, because it wouldn't require the inconvenience of weekly doctor visits or the pain of injections. Blouin said the new pill is intended only for ragweed, so if a person were allergic to other plants it would mean taking a separate pill for each one.
Last December, an FDA advisory committee voted unanimously to recommend approval of a similar kind of pill for grass pollen allergies, known as Grastek. Merck is developing that pill in partnership with a European company.
The FDA based Thursday's approval on the results of safety studies involving approximately 1,700 patients. Some of the patients who were treated with Ragwitek experienced itching in the mouth, and ear and throat irritation. Of the 1,700 patients, about 760 were evaluated for effectiveness. During one ragweed pollen season, patients who received Ragwitek saw a 26 percent reduction in symptoms and the need for medications, compared to those who received a placebo, the FDA said.
Visit the American College of Allergy, Asthma and Immunology (http://www.acaai.org/allergist/allergies/Types/Pages/ragweed-allergy.aspx ) for more on ragweed allergy.
SOURCES: U.S. Food and Drug Administration, news release, April 17, 2014; Len Horovitz, M.D., pulmonary specialist, Lenox Hill Hospital, New York City; William Blouin, MSN, ARNP, CPN, allergy and immunology nurse practitioner, Miami Children's Hospital; U.S. Food and Drug Administration briefing documents
Salmonella Cases Dip in U.S., But Food Poisoning Rates Remain High
New CDC report finds certain contaminants, such as Vibrio and E. coli, on the rise
THURSDAY, April 17, 2014 (HealthDay News) -- While the United States has seen a decline in the number of Salmonella illnesses in recent years, there's been little progress overall in reducing food poisoning outbreaks, health officials say.
"The news is mixed," Dr. Robert Tauxe, deputy director of the U.S. Centers for Disease Control and Prevention's Division of Foodborne, Waterborne and Environmental Diseases, said during a noon press briefing. "Some improvements were made, but substantial more work is needed."
Rates of illnesses due to Vibrio, a bacterial toxin found in shellfish, have actually spiked recently, the CDC noted.
The new report tracked patterns of foodborne illness outbreaks for 10 states. In 2013, the CDC's food poisoning reporting system identified 19,000 related infections, 4,200 hospitalizations, and 80 deaths among the 48 million residents of these states.
Salmonella remains the most frequent cause of food poisoning, accounting for 38 percent of all cases, Tauxe said. Second was the Campylobacter bacterium, which accounted for 35 percent of foodborne infections. Both Salmonella and Campylobacter can contaminate meat, chicken and vegetables, Tauxe said.
But there was some good news: In 2013, the rate of Salmonella infections fell by 9 percent, compared with the rate in 2010-2012, the CDC report found. "This drop brings Salmonella down to the rate we saw back in 2006-2008," Tauxe noted.
But the current rate of Salmonella infections of 15 cases per 100,000 people is still below the goal of 11.4 per 100,000, which the CDC hopes to reach by 2020, he said.
Tauxe believes that some of the decline in Salmonella cases is the result of stopping a large outbreak of the bacteria in eggs in 2010, and subsequent U.S. Food and Drug Administration (FDA) regulation mandating continuous refrigeration of eggs from farm to store.
On the other hand, however, Campylobacter infections have risen 13 percent since 2006-2008 and have remained stable over the past five years, Tauxe said.
Cases of illness from the Vibrio bacteria, found in raw shellfish, still account for only 1 percent of food poisoning cases but have been on the rise. "Vibrio infections have continued to increase as they have in the past," Tauxe said. "We are at the highest level observed since our tracking began in 1996."
Since 1996, Vibrio infections have climbed 168 percent, and cases rose by one-third in just the last three years, he said.
In addition, food poisoning from another bacteria, E. coli, have also been creeping up again after a period of decline. "The progress that has been noted since 2006-2008 [against E. coli] has stalled," he said. "Still, E. coli infections are 30 percent lower than they were in 1996."
Those most affected by food poisoning were children under 5 and adults 65 and older, according to Tauxe.
Dr. Marc Siegel, an associate professor of medicine at NYU Langone Medical Center in New York City, said the only way to curb food poisoning is with more and stricter regulation.
"We overtreat animals and people with antibiotics, which breeds strains of these bacteria that are resistant to drugs," he believes. "That's the problem right there."
Siegel also contends that the ways animals are raised -- in overcrowded conditions, often living in their own waste -- is a breeding ground for harmful bacteria.
"More oversight and testing for these bacteria is needed," he said.
To help reduce the threat of food poisoning, the FDA and the U.S. Department of Agriculture say they are coming up with new plans and regulations, including new standards for cut-up poultry parts and ground chicken and turkey.
Consumers and the food industry also have a role to play, the CDC noted. Companies can use safer ingredients and can institute controls to prevent shipping contaminated food.
In addition, restaurants and consumers can follow safe practices in their kitchens. These include cooking meat to proper temperatures, washing produce, and preparing meat and fresh vegetables on different surfaces.
Consumers should also know there are risks to eating unpasteurized milk, soft cheeses made with unpasteurized milk and raw oysters, the agency added.
The report was published April 18 in the CDC's Morbidity and Mortality Weekly Report.
For more information on avoiding food poisoning, visit Foodsafety.gov (http://www.foodsafety.gov/ ).
SOURCES: Marc Siegel, M.D., associate professor, medicine, NYU Langone Medical Center, New York City; April 17, 2014, press conference with Robert Tauxe, M.D., M.P.H., deputy director, Division of Foodborne, Waterborne and Environmental Diseases, U.S. Centers for Disease Control and Prevention; April 18, 2014, Morbidity and Mortality Weekly Report
Misdiagnoses Common Among U.S. Outpatients: Review
5 percent of adults are affected each year, data from several studies suggest
WEDNESDAY, April 16, 2014 (HealthDay News) -- At least 5 percent of American adults -- 12 million people -- are misdiagnosed in outpatient settings every year, and half of these errors could be harmful, a new study indicates.
The findings, from an analysis of data from several published studies, should lead to greater efforts to monitor and reduce the number of misdiagnoses that occur in primary care, said Dr. Hardeep Singh, at Baylor College of Medicine, and colleagues.
Primary care is given outside the hospital, such as in doctors' offices and outpatient clinics.
The researchers noted that most efforts to improve patient safety have focused on hospitalized patients and on issues such as medication errors, infections and falls. However, the researchers added, most diagnoses are made in outpatient facilities.
There have been no reliable estimates of how often misdiagnoses occur in outpatient settings, making it difficult to develop methods of reducing such errors, according to the authors of the study published online April 16 in the journal BMJ Quality & Safety.
The researchers' review of the published studies involving U.S. adults showed that outpatient facilities have a misdiagnosis rate of just over 5 percent, or about one in 20 patients. Applied to the U.S. population, that means that 12 million adults are misdiagnosed in outpatient settings each year, according to a journal news release.
The results should be used by patient advocates, health care organizations, policymaker and researchers to seek ways to reduce the number of such misdiagnoses, the study authors concluded.
The U.S. Agency for Healthcare Quality and Research offers tips to prevent medical errors (http://www.ahrq.gov/patients-consumers/care-planning/errors/20tips/ ).
SOURCE: BMJ Quality & Safety, news release, April 16, 2014
Off Season May Not Be Long Enough to Recover From Football 'Hits'
Study found some players still showed brain changes 6 months after season had ended
THURSDAY, April 17, 2014 (HealthDay News) -- New research shows that the brains of some football players who had the usual head hits associated with the sport, but no concussions, still had signs of mild brain injury six months after the season ended.
"We followed athletes at the beginning of football season, after and for six months later," said Dr. Jeffrey Bazarian, an associate professor of emergency medicine at the University of Rochester School of Medicine and Dentistry, in Rochester, N.Y.
Bazarian found white matter changes consistent with mild brain injury generally persisted for six months. "When we looked at players individually, there were a few that looked like they did resolve," he said, but half of the players still showed changes at the six-month mark.
"We didn't see these changes in those who don't play football," he said. "And these are the kinds of changes that are being found in retired NFL players."
The latest study is published in the April 16 online issue of PLOS ONE.
For the research, Bazarian evaluated 10 Division III college football players and five college students who did not play sports during the 2011-2012 season. All 15 underwent brain imaging in addition to balance, cognitive (thinking) skills and other testing before the season, at the end of the season and after six months of rest. The athletes were told not to play during the six months, he said, although the researchers can't be sure everyone followed that instruction.
During the football season, accelerometers mounted to the helmets measured head impacts. The total head impacts for the season ranged from 431 to 1,850, but no one got a diagnosis of concussion.
A concussion is a brain injury that disrupts normal functioning. In recent years, experts have told coaches, players and parents that athletes should not return to play until a doctor evaluates them if a concussion is suspected.
In the new study, the athletes had more changes in white matter from the first measurement to the second, and most of these differences remained at the final measure, six months after play had stopped.
The lack of recovery could contribute to the white matter changes that accumulate over the years with repetitive head impacts, the researchers noted.
"We are obviously trying to understand, are these changes the beginning of this process?" Bazarian said. They also need to find out why some brains recover more quickly, he added.
"Inflammation may be at play," Bazarian said. "If that's the case, maybe it's a case of preventing inflammation. Maybe more than six months of rest is needed."
The researchers can't say if the changes are "clinically meaningful," Bazarian said. "We found no changes in balance or cognition."
One expert noted there were some limitations to the study.
The findings are "very preliminary," said Dr. John Kuluz, director of traumatic brain injury and neurorehabilitation at Miami Children's Hospital. "It's only a small number of athletes."
Kuluz added that comparing football players to nonathletes was also not ideal. "It would have been much better having swimmers or track and field athletes, some sport where they are not hit on the head."
The white matter changes, as the researchers noted, could have been due to physical exertion, not just the impacts to the head.
However, Bazarian said the findings raise questions about whether hits that fall short of concussions can still lead to neurological problems.
If the research bears out in future studies, one solution may be to take football players out of play when head impacts reach a certain number, to protect their brains.
Until more is known, athletes should pay attention to symptoms suggesting a concussion and get medical help if one is suspected. Headaches, trouble with concentration, sensitivity to light or sound and dizziness are common symptoms of a concussion.
Bazarian reports a pending patent on a method of diagnosing concussion.
The study was funded by the National Football League Charities.
To learn more about concussions, visit the American Academy of Pediatrics (http://www.healthychildren.org/English/health-issues/injuries-emergencies/sports-injuries/pages/Concussions.aspx ).
SOURCES: Jeffrey Bazarian, M.D., associate professor, emergency medicine, University of Rochester School of Medicine and Dentistry, Rochester, N.Y.; John Kuluz, M.D., director, traumatic brain injury and neurorehabilitation, Miami Children's Hospital; April 16, 2014, PLOS ONE, online
FDA Warns Against Procedure for Uterine Fibroids
'Laparoscopic power morcellation' may increase women's cancer risk, agency says
THURSDAY, April 17, 2014 (HealthDay News) -- A surgical technique used to grind up uterine growths and remove them through tiny incisions could increase a woman's risk of cancer, the U.S. Food and Drug Administration warned Thursday.
The FDA said that the procedure, known as "laparoscopic power morcellation," can inadvertently spread cancerous tissue beyond a woman's uterus and into other parts of her body.
Surgeons frequently use laparoscopic power morcellation when they perform a hysterectomy or remove uterine fibroids, which are noncancerous growths on the smooth muscle tissue on the wall of the uterus.
The minimally invasive procedure uses a power tool to chop up the tissue of the fibroids or, in the case of a hysterectomy, the uterus itself. These tissue fragments are then removed through tiny incisions, according to background information from the agency.
The FDA estimates that about one in 350 women undergoing a hysterectomy or fibroid removal has an unsuspected type of cancer called uterine sarcoma.
If a surgeon performs power morcellation on these women, there's a risk the procedure will spread the cancerous tissue within the patient's abdomen and pelvis.
About 60,000 of these procedures are performed every year, estimated Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health.
The FDA stopped short of banning the power morcellation device from the market, but is urging physicians and patients to weigh the risk prior to its use.
"Women should ask their health care provider if power morcellation will be used during the procedure, and explain why it's the best option," Maisel said at a Thursday news conference.
Women who already have undergone power morcellation don't need to get a cancer screening, because some of the tissue removed during the procedure would have been sent for pathologic analysis, Maisel said. If cancer had been detected, they would have been informed, he added.
"We think that most women who have undergone these procedures require routine care," he said. "If they don't have any ongoing or recurrent symptoms, they should be fine."
Most women will develop uterine fibroids at some point in their lives, according to the U.S. National Institutes of Health. These fibroids can cause symptoms such as heavy or prolonged menstrual bleeding, pelvic pain or frequent urination.
Women who need a hysterectomy or fibroid removal can still undergo traditional or laparoscopic surgery, just without the use of a power morcellator, Maisel said.
The agency has instructed manufacturers of power morcellators to review their current product labeling for accurate risk information for patients and health care professionals.
The FDA also will convene a public meeting this summer of its obstetrics and gynecological medical devices panel to discuss the matter and weigh whether further measures are required.
The FDA approved the first power morcellator for use in 1995, Maisel said. A non-power version of the morcellator received FDA approval in 1991.
The medical community has been aware of the risk of cancer spread during power morcellation since the device came onto the market, but "the magnitude of the risk appears to be higher than what was appreciated in the clinical community," Maisel said.
Brigham and Women's Hospital in Boston and the Cleveland Clinic both recently strengthened their informed consent for the procedure, warning women of the potential cancer risk, according to recent news reports.
In particular, specialists at Brigham and Women's tell patients about their own in-house research, which found a ninefold higher rate of unexpected uterine sarcoma during a review of the medical records of more than 1,000 women who received morcellation for fibroids, according to The New York Times.
For more about uterine sarcoma, visit the U.S. National Cancer Institute (http://www.cancer.gov/cancertopics/types/uterinesarcoma ).
SOURCES: April 17, 2014, U.S. Food and Drug Administration news briefing with William Maisel, M.D., M.P.H., deputy director for science and chief scientist, Center for Devices and Radiological Health; March 17, 2014, The New York Times; Dec. 24, 2013, Wall Street Journal
Bacteria May Survive Longer in Contact Lens Solution Than Thought
Study suggests manufacturers test for all strains of P. aeruginosa to prevent infection
THURSDAY, April 17, 2014 (HealthDay News) -- Bacteria that can cause serious eye infections are able to survive longer in contact lens cleaning solution than previously known, a new study finds.
Researchers looked at different strains of Pseudomonas aeruginosa, which can cause microbial keratitis. This is an inflammation and ulceration of the cornea that can cause vision loss.
The investigators tested nine strains of P. aeruginosa gathered from hospital patients in Britain and compared them to P. aeruginosa strain 9027, which is the standard one used in tests by makers of contact lens disinfectant solutions.
Most of the strains were killed within 10 minutes after being placed in the contact lens solution, a result comparable to strain 9027. However, strain 39016 -- which causes more severe cases of keratitis with a longer healing time -- survived in the solution for more than four hours.
The findings, scheduled for presentation Wednesday at a Society for General Microbiology meeting in Liverpool, England, suggest that tests of contact lens solutions should determine if they can kill all P. aeruginosa strains, the University of Liverpool researchers said.
"Microbial keratitis can be devastating for a patient -- it is important that the risk of developing this condition is reduced in contact lens wearers by improving contact lens disinfectant solutions," study leader Craig Winstanley said in a society news release.
Because this study was presented at a medical meeting, it should be viewed as preliminary until published in a peer-reviewed journal.
Each year in the United Kingdom, there are about 6,000 cases of microbial keratitis, the news release noted.
The American Academy of Ophthalmology has more about contact lens-related eye infections (http://www.geteyesmart.org/eyesmart/diseases/contact-lens-related-infections.cfm ).
SOURCE: Society for General Microbiology, news release, April 16, 2014